Sr. Manager - Infotech (Manufacturing Compliance Lead)

Brief JD -

• Collaborate with leadership from Production, Quality, Engineering, Subject Matter Experts (SMEs) for effective and successful application implementation in defined timelines.
• Experience in facing regulatory inspections like USFDA, MHRA, EMA etc.
• Excellent skills of resource handling and people management
• Good understanding on handling of GxP Applications/software implementation
  • IPC/HMI/Scada based System.
  • PC based systems in manufacturing and quality domain
  • QMS system like caliber, Track-wise. etc
  • LIMS (Laboratory Information Management Systems
  • C-DAS (Central Data acquisition systems)
  • Chromeleon
• Good understanding of Enterprise & site-specific software new implementations & upgrades.
• Good understanding on handling of IT infrastructure/tools
  • Network components
  • Servers/database
  • Operating systems
  • Security tools

• Harmonization and Implementation of best-in-class practices & procedure to improve IT efficiency and compliance.
• Management of application vendors, implementation partners and other support teams.
• Stakeholder and Conflict management.

IT Compliance Handling:

• Knowledge of CSV as per GAMP, 21 CFR Part 11, EU Annexure-11 and compliance practices.
• Excellent skills in investigation report & SOP writing
• Good understanding of QC and manufacturing systems in line with Data integrity aspect.
• Ensure IT application activities are executed according to regulatory compliance standards and IT security norms.
• Excellent Understanding on IT related change control, CAPA, deviations and incident etc.  
• Good Skills to deliver training across the IT domain.
• Participating in periodical SOP reviews and facilitating for various internal/External audits.
• Budget management and cost monitoring.
• Any additional responsibilities as assigned

Experience - 15+ Years in Pharma IT

Qualification - B.E / B.Tech